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TV P2-VP8
TV P2-VP8 is a Biologic drug developed by PATH. It is currently in Phase 3 development for COVID-19.
TV P2-VP8 is a vaccine candidate.
Trivalent P2-VP8 is a small molecule subunit rotavirus vaccine. It is being studied in a Phase II clinical trial for its immunogenicity and safety in combination with Rotarix and RV3-BB in preventing rotavirus infection in children.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TV P2-VP8 |
|---|---|
| Sponsor | PATH |
| Modality | Biologic |
| Therapeutic area | Vaccine |
| Phase | Phase 3 |
Mechanism of action
TV P2-VP8 is a vaccine candidate that aims to provide protection against a specific disease. The exact mechanism of action is not publicly available.
Approved indications
- COVID-19
Common side effects
- Injection site pain
Key clinical trials
- Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine (PHASE2)
- A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TV P2-VP8 CI brief — competitive landscape report
- TV P2-VP8 updates RSS · CI watch RSS
- PATH portfolio CI
Frequently asked questions about TV P2-VP8
What is TV P2-VP8?
How does TV P2-VP8 work?
What is TV P2-VP8 used for?
Who makes TV P2-VP8?
What development phase is TV P2-VP8 in?
What are the side effects of TV P2-VP8?
Related
- Manufacturer: PATH — full pipeline
- Therapeutic area: All drugs in Vaccine
- Indication: Drugs for COVID-19
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing